Posted by Michael Wonder on 18 Feb 2020
PharmaMar and Jazz Pharmaceuticals announce FDA acceptance and priority review of new drug application for lurbinectedin in relapsed small cell lung cancer
17 February 2020 - Prescription Drug User Fee Act date set for 16 August 2020.
PharmaMar and Jazz Pharmaceuticals announce that the U.S. FDA accepted for filing with Priority Review the New Drug Application (NDA) seeking accelerated approval for lurbinectedin for the treatment of patients with Small Cell Lung Cancer (SCLC) who have progressed after prior platinum-containing therapy.
PharmaMar submitted the NDA to FDA in December 2019 based on data from the Phase II monotherapy basket trial, which included evaluation of lurbinectedin for the treatment of relapsed SCLC. A total of 105 patients from 39 centers were recruited in Europe and the United States. The trial met its primary endpoint of the Objective Response Rate (ORR) and the results were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2019.
